The Food and Drug Administration told two drug companies in separate warning letters it will refuse entry of their active pharmaceutical ingredients (APIs) unless they correct violations of current good manufacturing practice requirements (CGMP). In a letter dated March 18 sent to GlaxoSmithKline (here), FDA said CGMP violations at the company’s Cork, Ireland facility may result in APIs from that facility being placed on import alert and being refused admission. Meanwhile, an agency warning letter dated March 6 told Smruthi Organics in India that its APIs will continue to be refused admission into the U.S. because of persisting CGMP violations (here).
On April 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued a final rule adopting in full its interim regulations expanding the agency’s access to food records. FDA had implemented the Food Safety Modernization Act recordkeeping changes in a February 2012 interim final rule (see 12022320). Under the now-adopted interim regulations, FDA not only has the right to access company records on an article of food that presents a food safety risk, but also any article FDA “reasonably believes” is affected in a similar manner, as well as any food for which FDA believes there is a “reasonable probability” of food safety risks.
The Food and Drug Administration issued its weekly Enforcement Report for April 2 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On April 1 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of March 24-30, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
On March 31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration said it will hold a meeting May 8-9 in Silver Spring, Md., to discuss implementation of drug supply chain tracing provisions of the Drug Supply Chain Security Act. The “public workshop” will provide a forum for discussing the development of standards for the interoperable exchange of product tracing information, said FDA. Participants will also discuss the feasibility of establishing standardized documentation for product tracing purposes. Registration is required by April 24.
On March 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: